EUCTR2015-001605-14-GB进行中（未招募）1 期
A Randomised, double-blind, placebo controlled, multi-centre phase II study to assess the Efficacy and safety of 2nd line Olaparib in combination with Paclitaxel, in Western patients with advanced gastric and gastro-oesophageal junction cancer - OPERa
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Advanced gastric or gastro-oesophageal junction cancer (HER2 positive or negative) which has progressed following first line treatment
- •2. Male and female patients must be aged 18 or above*
- •3. Availability of a tissue sample (resection or biopsy) confirming gastric or gastro-oesophageal junction adenocarcinoma*
- •4. At least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI)
- •5. Provision of fully informed consent*
- •6. Adequate organ and bone marrow function measured within 28 days prior to starting treatment as detailed below:
- •- Haemoglobin = 10.0 g/dL and no blood transfusions in the 28 days prior to study entry
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- White blood cells (WBC) > 3 x 109/L
- •- Platelet count = 100 x 109/L
- •- Total bilirubin = 1.5 x institutional upper limit of normal (ULN)
- •- AST/ ALT = 2.5 x institutional ULN (unless liver metastases are present in which case it must be = 5x ULN)
- •- Serum creatinine = 1.5 x institutional upper limit of normal (ULN)
- •7. ECOG performance status of 2 or less
- •8. Life Expectancy of 16 weeks or more
- •9. Evidence of non-childbearing status for women of childbearing potential (ie negative urine or serum pregnancy test within 7 days of study treatment) or postmenopausal status.
- •Postmenopausal status is defined as:
- •- Amenorrheic for 1 year or more following cessation of exogenous hormonal
- •treatments,
- •- LH and FSH levels in the post menopausal range for women under 50,
- •- radiation-induced oophorectomy with last menses >1 year ago,
- •- chemotherapy-induced menopause with >1 year interval since last menses,
- •- or surgical sterilisation (bilateral oophorectomy or hysterectomy).
- •10. Patient is willing and able to comply with the protocol for the duration of the study including having examinations, undergoing treatment and attending scheduled visits (including follow up).
- •11. Patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception throughout their participation in the study and for 3 months after last dose of study drug(s). For example condom with spermicide and oral contraceptive/hormonal therapy or condom with spermicide and placement of an intra-uterine device.
- •* Starred inclusion criteria must be met for enrolment to the pre-screening part of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. More than 1 prior chemotherapy regimen used for the treatment of advanced gastric cancer (except for adjuvant/neoadjuvant chemotherapy which is permitted except with a taxane- see below)
- •2. Any previous treatment with a PARP inhibitor, including olaparib*
- •3. Any second primary cancer (except adequately treated non-melanoma skin cancer, curatively treated cervical carcinoma-in-situ and curatively treated other solid tumours with no evidence of disease for 5 years or more)
- •4. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons) or investigational product within 2 weeks from the last dose prior to starting treatment (or a longer period depending on the defined characteristics of the agents used). A stable dose of bisphosphonates is permitted for bone metastases before and during the study as long as they were started at least 4 weeks prior to starting treatment
- •5. Clinically significant heart disease or myocardial infarction within the previous 12 months
- •6. Interstitial pneumonia or symptomatic fibrosis of the lungs
- •7. Active brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with known brain metastases are eligible if they have been treated and there is no evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Patients can take a stable dose of corticosteroids before and during the study as long as these were started 4 or more weeks prior to treatment
- •8. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any previous major surgery
- •9. Pregnant and breastfeeding women
- •10. Patients considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.
- •11. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication absorption
- •12. Persistent toxicities (of CTCAE grade 2 or above) with the exception of alopecia, caused by previous cancer therapy.
- •13. Immunocompromised patients e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
- •14. Patients with known active hepatic disease (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
- •15. Patients with intestinal obstruction or patients with CTCAE grade = 3 upper GI bleeding within 4 weeks of study entry
- •16. Any previous treatment with a taxane in the metastatic or recurrent setting. (A taxane may have been used in the neoadjuvant or adjuvant setting, as long as progression occurred more than 6 months following completion of treatment)*
- •17. Patients receivi
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